A new medical device that could save thousands of lives by preventing overdoses was approved on April 1, 2014, by the U.S. Food and Drug Administration.
Experts applauded the F.D.A.’s decision, saying it could lead to the broad dissemination of the drug, which has rarely been available to the families and friends of drug abusers, who are often the first to find them when they have overdosed.
The hand-held device, called Evzio - the emergency treatment works like the well-known EpiPen- delivers a single dose of naloxone, a medication that reverses the effects of an overdose. It is injected into the muscle and does not require training, making it more user-friendly.
Once injected, the naloxone stops heroin and other opioids from slowing a person's breathing down to the point that it stops. Naloxone is the standard treatment in such circumstances and has long been used in hospitals, ambulances and other medical settings, when it is often used too late to save the patient.
Evzio now allows nonmedical personnel to carry the drug in a pocket or to store it in a medicine cabinet. Once turned on, the new instruments will give verbal instruction about how to deliver the medication, similar to automated defibrillators that hang in public buildings.
Food and Drug Administration officials said they speedily approved the device because it is critical to prevent deaths. The FDA approved the prescription treatment after just 15 weeks under priority status.
The decision to quickly approve the new treatment, which is expected to be available this summer, comes as deaths from opioids continue to mount, including an increase in those from heroin, which contributed to the death of the actor Philip Seymour Hoffman in February.
Federal health officials, facing criticism for failing to slow the rising death toll, are under pressure to act, experts say. “This is a big deal, and I hope gets wide attention,” said Dr. Carl R. Sullivan III, director of the addictions program at West Virginia University.
“It’s pretty simple: Having these things in the hands of people around drug addicts just makes sense because you’re going to prevent unnecessary mortality.”
Deaths have climbed despite efforts by states and the federal government. The scourge of drug abuse has battered states across the country, with deaths from overdoses now outstripping those from traffic crashes.
Prescription drugs alone now account for more than half of all drug overdose deaths, and one major category of them, opioids, or painkillers, take the lives of more Americans than heroin and cocaine combined.
Deaths from opioids have quadrupled in 10 years to more than 16,500 in 2010, according to federal data. Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston, whose company, Analgesic Solutions, develops treatments for pain, said the approval would “catalyze the adoption of this treatment.”
“We have 17,000 fatal opioid overdoses every year,” he said. “You can potentially prevent a chunk of them with this technique.” Dr. Eric Edwards, chief medical officer of Kaléo, the pharmaceutical company that produces Evzio, said naloxone treatment used outside hospitals today involved injectable formulations with glass vials, syringes and, in about half the cases, attachments requiring assembly to create a nasal spray.
The new device is the shape of a credit card, the thickness of a cellphone, and has a contractible needle the user never even sees.